Quality & complianceOfficial

Dutch inspectorate flags sterile packaging failure on BS-MTI Tumorstent Innoflex Mono ureteral stent

🇳🇱 IGJ · Thu 05 Nov 2026

IGJ reports that the stent's sterile packaging failed a microbial barrier test after five years of real-time aging, leaving its claimed five-year shelf life unsupported.

The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer warning on the IMP Tumorstent Innoflex Mono ureteral stent, made by BS Medical Tech Industry (BS-MTI). The notice is dated 6 November 2026 on the IGJ site, and the manufacturer's Field Safety Notice (FSN) carries the date 29 October 2026.

The issue concerns the sterile packaging. According to the notice, the packaging failed the microbial barrier test after five years of real-time aging. As a result, there is no evidence that the packaging can keep the product sterile over a five-year shelf life.

The material published by IGJ does not say which lots or production dates are affected, how many devices are on the market, or whether any infections or patient harm have been reported. It also does not describe the corrective actions the manufacturer is asking users to take. Those details are presumably set out in the two-page FSN that IGJ links to, but they are not in the text available here.

IGJ notes that manufacturers must monitor their devices after they are placed on the market and improve them where necessary. Where a risk to users exists, the manufacturer must act and inform users and the inspectorate through a Field Safety Notice.

What it means for your team

  • Quality and regulatory teams at hospitals and distributors should obtain the full FSN from IGJ or the manufacturer to check affected lots, expiry dates and required actions.
  • The case illustrates the importance of real-time aging data to support claimed shelf life and sterile barrier integrity, beyond accelerated studies.
  • Manufacturers with long shelf-life claims for sterile devices may wish to review their packaging validation and ongoing stability data.
  • Vigilance teams should note that no patient harm or affected quantities are stated in the published text.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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